BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Express Scripts
Argus Health
Cantor Fitzgerald
Fish and Richardson
Federal Trade Commission

Generated: December 15, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 018741

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NDA 018741 describes DIPROLENE, which is a drug marketed by Schering and Merck Sharp Dohme and is included in four NDAs. It is available from two suppliers. Additional details are available on the DIPROLENE profile page.

The generic ingredient in DIPROLENE is betamethasone dipropionate. There are sixty-six drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the betamethasone dipropionate profile page.

Summary for 018741

Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Adrenal)
Formulation / Manufacturing:see details

Pharmacology for NDA: 018741

Suppliers and Packaging for NDA: 018741

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPROLENE betamethasone dipropionate OINTMENT, AUGMENTED;TOPICAL 018741 NDA Merck Sharp & Dohme Corp. 0085-0575 0085-0575-05 1 TUBE in 1 BOX (0085-0575-05) > 50 g in 1 TUBE
DIPROLENE betamethasone dipropionate OINTMENT, AUGMENTED;TOPICAL 018741 NDA Merck Sharp & Dohme Corp. 0085-0575 0085-0575-02 1 TUBE in 1 BOX (0085-0575-02) > 15 g in 1 TUBE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT, AUGMENTED;TOPICALStrengthEQ 0.05% BASE
Approval Date:Jul 27, 1983TE:ABRLD:Yes

Expired Orange Book Patents for NDA: 018741

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck Sharp DohmeDIPROLENEbetamethasone dipropionateOINTMENT, AUGMENTED;TOPICAL018741-001Jul 27, 1983► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

US Department of Justice
US Army
Daiichi Sankyo
Johnson and Johnson
Boehringer Ingelheim

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